Staff Quality Compliance Engineer

📋 Description

• • Join PROCEPT BioRobotics Corporation, a pioneering company dedicated to revolutionizing the treatment of benign prostatic hyperplasia (BPH) through innovative surgical robotics. We are driven by a vision to put patients first, enhance surgical options for physicians, and deliver value to our shareholders. Our commitment extends to our people, fostering an environment of continuous career growth and transformative opportunities.
• • As a Staff Quality Compliance Engineer, you will play a pivotal role in shaping and executing strategies to elevate the compliance, effectiveness, and efficiency of our Quality Compliance and Post-Market Surveillance (PMS) functions. This is a critical position that requires a proactive and strategic mindset to ensure our quality systems not only meet but exceed regulatory standards.
• • You will be the primary representative for Quality Compliance and PMS in collaborations with internal departments and cross-functional stakeholders. This involves actively engaging with process owners to understand current workflows, identify areas for enhancement, and drive the implementation of improvements.
• • A key responsibility will be the development and implementation of sophisticated quality tools designed to monitor essential quality metrics. These metrics will serve as vital indicators of the health and robustness of our overall Quality System, providing data-driven insights for strategic decision-making.
• • You will be instrumental in identifying opportunities for continuous improvement across all quality compliance processes. This includes analyzing existing workflows, identifying bottlenecks or inefficiencies, and proposing innovative solutions that align with our growth and evolving business needs.
• • This role demands a deep understanding of regulatory requirements and industry best practices in medical device quality systems. You will be expected to stay abreast of changes in regulations (e.g., FDA, ISO 13485, MDR) and proactively adapt our processes to maintain compliance.
• • You will contribute to the development and maintenance of Standard Operating Procedures (SOPs), work instructions, and other quality documentation, ensuring they are accurate, up-to-date, and effectively implemented across the organization.
• • Partnering with R&D, Manufacturing, and other departments, you will ensure that quality considerations are integrated into product development lifecycle, from design to post-market activities.
• • You will be involved in internal and external audits, providing support and ensuring that our quality system is audit-ready at all times. This includes preparing documentation, responding to auditor inquiries, and implementing corrective actions as needed.
• • The role requires a strong analytical capability to interpret data, identify trends, and translate findings into actionable recommendations for process improvement and risk mitigation.
• • You will contribute to the development and execution of risk management activities, ensuring that potential risks associated with our products and processes are identified, assessed, and controlled.
• • This position offers a unique opportunity to make a significant impact on patient safety and product quality by ensuring the highest standards of compliance are maintained within a rapidly growing and innovative medical technology company.
• • You will be expected to lead and mentor junior quality engineers or technicians as needed, fostering a culture of quality and continuous improvement within the team.
• • The Staff Quality Compliance Engineer will actively participate in cross-functional teams to address quality issues, implement corrective and preventive actions (CAPAs), and drive a culture of quality throughout the organization.
• • You will be responsible for ensuring that all quality compliance activities are documented thoroughly and accurately, in accordance with regulatory requirements and company policies.
• • This role is crucial for maintaining PROCEPT BioRobotics' reputation for quality and reliability in the competitive medical device market.
• • You will contribute to the development and implementation of training programs related to quality compliance for relevant personnel.
• • The successful candidate will possess a strong understanding of quality system elements such as document control, change control, training, internal audits, management review, and CAPA.
• • You will be a key player in ensuring that our Quality Management System (QMS) is robust, effective, and compliant with all applicable global regulations and standards.
• • This position requires a collaborative approach, working closely with various departments to achieve shared quality objectives and promote a unified approach to compliance.
• • You will be expected to proactively identify and address potential compliance gaps before they become significant issues, demonstrating a forward-thinking and preventative approach to quality management.
• • The role involves continuous learning and development to stay current with evolving regulatory landscapes and technological advancements in the field of medical robotics and quality assurance.
• • You will contribute to the development and refinement of key performance indicators (KPIs) for the Quality Compliance and PMS function, ensuring alignment with strategic business goals.
• • This role is ideal for an experienced quality professional looking to take on greater responsibility and make a substantial impact within a dynamic and mission-driven organization.
• • You will be a champion for quality, advocating for best practices and fostering a strong quality culture across PROCEPT BioRobotics.
• • The Staff Quality Compliance Engineer will be responsible for ensuring that all quality-related activities are performed in accordance with the company's Quality Policy and objectives.
• • You will actively participate in the evaluation and implementation of new quality management software or tools to enhance efficiency and effectiveness.
• • This position offers the chance to work with cutting-edge technology and contribute to life-changing medical devices.
• • You will be a key contributor to the ongoing success and growth of PROCEPT BioRobotics by ensuring the highest standards of product quality and regulatory compliance are met.
• • The role requires a commitment to ethical conduct and a strong sense of responsibility in upholding the company's commitment to patient safety and product integrity.
• • You will be involved in the review and approval of various quality-related documents and processes, ensuring adherence to established procedures and regulatory requirements.
• • This position provides an excellent platform for professional development and career advancement within the medical device industry.
• • You will be a critical link in ensuring that PROCEPT BioRobotics maintains its competitive edge through superior quality and compliance.